# K203780: Harvester SI: Sacroiliac Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinus International, Inc.
- Decided: Mar 23, 2021 after 85 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K930834 (1993). 143 ancestors in all.
No later device cites it as a predicate yet.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152237: The Entasis Dual-Lead Sacroiliac Implant, Corelink, LLC (2016) Summary page 5.
- K121148: Samba Screw, 9MM Dia., 25MM Long, Sambia Screw, 9MM Dia., 30MM Long, Samba Screw 9MM Dia., 35MM Long, Samba Screw, 9MM D, Medical Design, LLC (2012) Summary page 5.
- K183342: SambaScrew 3D SI Fusion System, Orthofix, Inc. (2019) Summary page 5.
- K201538: Life Spine SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2020) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.

## Indications for use
The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

Source page: https://510kreport.com/device/K203780
Methodology: https://510kreport.com/methodology